Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074578
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/22/1997 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/09/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/20/2005 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/25/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/25/2002 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/22/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/30/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/09/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
ACYCLOVIR
CAPSULE;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 075677 | APOTEX |
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 204313 | CADILA |
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 201445 | CADILA PHARMS LTD |
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 206261 | CARLSBAD TECHNOLOGY |
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 074889 | HERITAGE PHARMS |
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 075090 | INDOCO |
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 074578 | TEVA |
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 212173 | YILING |